Atezolizumab + Tiragolumab for Head and Neck Cancer
(SKYSCRAPER-09 Trial)

Recruiting in Palo Alto (17 mi)

+86 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hoffmann-La Roche

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.

Eligibility Criteria

This trial is for adults with recurrent or metastatic PD-L1 positive squamous cell carcinoma of the head and neck. Participants must have measurable disease, an ECOG status of 0 or 1, a life expectancy of at least 12 weeks, and no prior systemic therapy for their condition. They cannot join if they are pregnant, breastfeeding, have certain lung conditions or other cancers within the last five years, untreated brain metastases, rapid disease progression or recent immunotherapy.

Inclusion Criteria

I am fully active or can carry out light work.

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

You are expected to live for at least 12 more weeks.

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Exclusion Criteria

I have not had any cancer other than SCCHN in the last 5 years.

I am currently taking or have recently taken drugs that affect my immune system.

I have lasting side effects from past treatments or surgeries.

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Treatment Details

Interventions

Atezolizumab (Monoclonal Antibodies)
Placebo (Other)
Tiragolumab (Monoclonal Antibodies)

Trial OverviewThe study tests how well Atezolizumab combined with Tiragolumab works compared to Atezolizumab with a placebo in treating this type of cancer as a first-line treatment. It measures the rate at which tumors respond to these treatments and also looks into safety and how the body processes these drugs.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Atezolizumab + TiragolumabExperimental Treatment2 Interventions

Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.

Group II: Atezolizumab + PlaceboPlacebo Group2 Interventions

Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: